Safety Submission Associate

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Every day, we rise to the challenge to make a difference and here's how the Safety Submission Associate will make an impact:

Key responsibilities for this role include:

• Creates and imports submission content for PADERs utilizing an enterprise content management platform (i.e., Documentum).

• Collaborates with Regulatory Affairs to ensure US FDA 356h forms are completed appropriately for scheduled PADER submissions to the FDA.

• Records approval and submission dates in global safety database (i.e. Oracle Argus) upon receipt acknowledgment and prepares final submission documentation for case files.

• Creates cover letters in enterprise content management platform (i.e., Documentum) and obtains electronic signature approval for PADER submissions to FDA.

• Assists Lead Safety Submission Specialist in the generation of US PADERs.

• Assembles and bookmarks PADERs according to regulatory requirements.

• Generates all Author Support Documents associated with Global PSURs.

• Perform other duties as assigned.

The minimum qualifications for this role are:

• Minimum of HS diploma or equivalent and prefer 2 years of experience in pharmaceutical industry. However, a combination of experience and/or education will be taken into consideration.

• Prefer knowledge of US FDA regulatory agency requirements and guidances under North America responsibilities in relation to postmarketing periodic reporting and electronic submissions.

• Prefer advanced skills in publishing electronic submissions utilizing systems such as Documentum, as well as Oracle Argus, Adobe Acrobat Professional and Microsoft Office Suite.

• Ability to read and interpret general business documents. Ability to write routine reports and general business correspondence. Ability to work with peers and communicate basic concepts.

• Ability to add, subtract, multiply, and divide.

• Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.

• Typically sitting at a desk or table. Intermittently sitting, standing, walking or stooping. Periodic travel is required.

• Proficiency in speaking, comprehending, reading and writing English is required.

Exact compensation may vary based on skills, experience, and location. The salary range for this position is $37,000.00 - $80,000.00 USD.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.